Senior Manager, Aseptic Manufacturing Start-Up & Launch

Amgen; Dublin; On-site; EUR 99,000 - 133,000; Full time

Job summary

Amgen Dun Laoghaire seeks a Senior Manager Manufacturing to lead start-up, operational readiness and the transition to commercial manufacturing. You will oversee aseptic filling, formulation, parts preparation and material supply, building a capable, compliant organisation from day one with a safety, quality and continuous improvement culture.

Reporting to the Director of Manufacturing, you will guide PPQ, site qualification and readiness for launch, recruit and develop Manufacturing Managers,

Qualifications

• 8+ years of experience in pharmaceutical manufacturing or similarly regulated environments.
• 4+ years of people management and leadership experience.
• Experience leading teams through significant change, scale-up, start-up, commissioning, qualification, PPQ or commercial launch activities.
• Bachelor’s degree, or an equivalent combination of education and relevant experience.

Responsibilities

• Lead the Manufacturing Operational Readiness programme for Aseptic Filling, Formulation, Parts Preparation and Material Supply, ensuring people, procedures, training, systems, materials, equipment interfaces and governance are in place to support successful PPQ and commercial launch.
• Provide visible operational leadership for aseptic manufacturing activities, ensuring sterile manufacturing practices, contamination-control expectations; GMP compliance and inspection readiness are embedded in day-to-day operations.
• Working with the Manufacturing Director, Ensure the Aseptic Filling organisation is fully prepared to execute PPQ successfully, with appropriately trained personnel, robust shift coverage, clear standard work and effective escalation of process or quality risks.
• Recruit, coach and develop Manufacturing Managers and frontline leadership, creating a strong leadership pipeline and clear accountability throughout the organisation.
• Establish and sustain a strong safety, quality, compliance and patient-focused culture from day one; set clear behavioural expectations and ensure these remain central as the organisation grows.
• In collaboration with Mfg Director, build the Manufacturing organisation from the ground up, including workforce planning, recruitment, onboarding, capability development and succession planning.
• Support successful PPQ execution, ensuring operational teams are fully prepared, risks are understood and mitigated, and manufacturing performance meets schedule, quality and compliance expectations.
• In collaboration with Mfg Director, develop the operating model, team routines, tiered accountability, performance-management processes, and escalation pathways required for reliable day-to-day operations.
• Partner closely with Quality, Engineering, Supply Chain, EHS, Process Development, Validation, Automation and other cross-functional teams to deliver site start-up milestones and resolve barriers.
• Ensure plant resources and personnel are effectively planned and coordinated to safely meet product quality, production schedule, and cost objectives.
• Drive operational excellence through effective business systems, visual performance management, problem-solving capability and continuous improvement practices.
• Champion a digital mindset across the Manufacturing organisation, using data, digital tools and appropriate AI-enabled solutions to strengthen operational readiness, simplify work, improve decision-making and enhance team capability while maintaining GMP, data-integrity and quality expectations.
• Lead the response to manufacturing issues using structured root-cause analysis, robust corrective and preventative actions, and effective learning across the organisation.
• Provide Manufacturing operational expertise and user requirements to process development, technology transfer, equipment qualification and new product introduction activities.
• Build collaborative relationships across the site and contribute actively to the development of the wider ADL culture and leadership team.

Skills

Leadership

People management

Communication skills

Cross-functional teamwork

Change management

Problem solving

Education

Bachelor’s degree

Tools

AI-enabled tools

Job description

Amgen Dun Laoghaire seeks a Senior Manager Manufacturing to lead start-up, operational readiness and the transition to commercial manufacturing. You will oversee aseptic filling, formulation, parts preparation and material supply, building a capable, compliant organisation from day one with a safety, quality and continuous improvement culture.

Reporting to the Director of Manufacturing, you will guide PPQ, site qualification and readiness for launch, recruit and develop Manufacturing Managers,